Cleared Traditional

Med-Link Temp-pulse Oximeter

K202743 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Anesthesiology
Mar 2021
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K202743 is an FDA 510(k) clearance for the Med-Link Temp-pulse Oximeter, a Oximeter (Class II — Special Controls, product code DQA), submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 1, 2021, 164 days after receiving the submission on September 18, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K202743 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2020
Decision Date March 01, 2021
Days to Decision 164 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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